Los Angeles, California, United States. June 23, 2021: #FreeBritney rally at LA Downtown Grand Park during a conservatorship hearing for Britney Spears.

There’s More to Decision-Making Capacity than Cognitive Function

The Health Law, Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. Though the Workshop is typically open to the public, it is not currently, due to the COVID-19 pandemic. However, many of our presenters will contribute blog posts summarizing their work, which we are happy to share here on Bill of Health.

By James Toomey

The doctrine of capacity is a mess.

From Britney Spears’s high-profile struggles to establish her own capacity to the countless, quiet challenges of so many older adults, the doctrine of capacity, which requires people to have the cognitive functioning to understand the nature and consequences of a decision in order for it to be recognized in law, is vague, normatively and medically challenging, and inconsistently applied.

This is a big deal — at stake in every capacity case is whether, on the one hand, an individual may access the legal rights most of us take for granted, to enter into contracts, buy or transfer property, or get married or divorced; or, on the other, whether the legal system will ratify a decision the “real person” never would have made.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Alexander EgilmanAviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of July. The selections feature topics ranging from a discussion of issues related to FDA’s approval of aducanumab for the treatment of Alzheimer’s disease, to an analysis of the communication of survival data in cancer drug labels, to an evaluation of public-sector contributions to novel biologic drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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Map of remote execution requirements for advance directives.

Advance Care Planning in an Online World: State Law Activity and Challenges Since COVID-19

By Nikol Nesterenko, Jonathan Chernoguz, and Sarah Hooper

Advance care planning — the process by which an individual documents their wishes for health care in the event that they become incapacitated — has become particularly urgent during the COVID-19 pandemic.

However, individuals that wish to engage in advance care planning, and specifically to document their plans in a written form (i.e., advance directives), have faced significant hurdles due to legal execution requirements. State advance directive law often requires or presumes live, in-person witnessing or notarization, actions which were prohibited by social distancing orders or simply unsafe during the pandemic.

In this piece, we summarize the state of remote execution requirements for advance directives before and during the COVID-19 pandemic. Broadly speaking, while many states took some action in this regard, most did not enact comprehensive changes, and therefore failed to meaningfully facilitate remote execution of advance directives.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

The Current COVID-19 Surge, Eugenics, and Health-Based Discrimination

By Jacqueline Fox

COVID has shown us that the burdens and inequities that characterize everyday life for many Americans are not merely vestiges of an older time, but an honest reflection of our unwillingness to treat everyone with dignity and respect.

We have undergone an ethical stress test in the last 18 months. While many people have exhibited heroic commitments to their fellow citizens, much of our governmental response is indefensible in a society that professes to care for all of its members. This implies we are not such a society.

Rather, we are a society riddled with healthism — discrimination based on health status — and eugenics — a pseudo-science that arbitrarily elevates some human traits over others, much as we do with breeding dogs and horses.

As a result, although we are armed with the power to prevent much harm, we lack the will or inclination to use that power for our most vulnerable. Instead, we place different values on people’s lives using arbitrary definitions of quality, and treat people differently based on their health status. Examples include placing a lower value on a life because a person is older, disabled, or overweight.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

FDA Approves Aducanumab for Alzheimer’s Disease: An Unethical Decision?

By Beatrice Brown

On June 7, 2021, the U.S. Food and Drug Administration (FDA) announced the accelerated approval of aducanumab (Aduhelm), a biologic manufactured by Biogen for the treatment of Alzheimer’s disease.

The FDA’s decision, which went against the near-unanimous opinion of its own advisory committee following its meeting in November 2020, has been embroiled in controversy over whether the available evidence demonstrated benefits that outweigh the risks of the drug. Namely, questions remain whether: 1) the conflicting evidence from the two pivotal trials is sufficient to suggest clinical benefit worthy of approval; and 2) the surrogate measure used to justify its accelerated approval is actually correlated with clinical benefit.

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Hundred dollar bills rolled up in a pill bottle

Aducanumab: A Bitter Pill to Swallow

By Emily Largent

On June 7, the U.S. Food and Drug Administration (FDA) used the Accelerated Approval pathway to approve aducanumab, which will go by the brand name Aduhelm, to treat patients with Alzheimer’s disease (AD). Aducanumab, developed by Biogen, is the first novel therapy approved for AD since 2003. This news has left many experts stunned.

I have at least one colleague, Dr. Jason Karlawish, who has publicly stated that he will not prescribe aducanumab. Other clinicians have said they will only prescribe it reluctantly. These are individuals who have dedicated decades of their lives to treating patients with AD, to conducting path-breaking research and serving as investigators in clinical trials, and to advocating for public policies that will better serve AD patients and their families. Many have also seen their own families affected by AD. My colleagues are hardly indifferent to the suffering wrought by AD and would like to have a meaningful treatment to offer to patients and their families. But, they have concluded, aducanumab is not it.

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Person in nursing home.

Long-Term Care After COVID: A Roadmap for Law Reform

By Nina A. Kohn

Between May 2020 and January 2021, 94 percent of U.S. nursing homes experienced at least one COVID-19 outbreak. And nursing home residents — isolated from family and friends, dependent on staff often tasked with providing care to far more residents than feasible, and sometimes crowded into rooms with three or more people — succumbed the virus at record rates. By March 2021, nursing home residents accounted for a quarter of all U.S. COVID-19-related deaths.

The poor conditions in nursing homes that have been exposed by the pandemic are symptomatic of long-standing problems in the industry.

Fortunately, as I discuss in-depth in a new essay in the Georgetown Law Journal Online, there are a series of practical reforms that could readily improve the quality of nursing home care, in large part by changing the incentives for nursing home providers.

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Senior citizen woman in wheelchair in a nursing home.

COVID-19 and Dementia Care: Lessons for the Future

By Marie Clouqueur, Brent P. Forester, and Ipsit V. Vahia

Alongside the COVID-19 epidemic in the U.S., the country faces another public health epidemic: dementia, and particularly Alzheimer’s disease.

Currently one in nine older adults in the U.S. — 6.2 million — have Alzheimer’s disease. The number of adults with Alzheimer’s in the U.S. will increase rapidly as the Baby Boomers age — it is expected to double by 2050.

The COVID-19 pandemic has exacerbated the situation. Acute, surging demand for dementia care services will turn into a persistent problem if we do not increase our capacity for services and better support our frontline workers. We have a chance now to reflect and take action to prepare for what is coming.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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Emergency room.

Worsening Health Inequity During Pandemic for People Experiencing Homelessness

This piece was adapted from a post that originally ran at On the Flying Bridge on March 28, 2021.

By Michael Greeley

With great fanfare last week, DoorDash announced an initiative to provide same-day home delivery of approved COVID-19 test collection kits.

Much of the business model innovation in health care today is to move as much care as is feasible to the home. But what does that mean for the homeless?

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